Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes — IMIGASTRICII  

Gastric Cancer Clinical Trial

Official title: Prospective, Observational, Multicenter Study on Minimally Invasive Gastrectomy for Gastric Cancer: Robotic, Laparoscopic and Open Surgery Compared on Operative and Follow-up Outcomes

Status Recruiting

Clinical Trial Summary

The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.

The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.

Clinical Trial Description

A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:

• Small samples of patients, mostly low-quality comparative studies

• Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)

• Absence of subgroup analysis in significant research fields

• Lack of information on the surgical techniques adopted

A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:

• Achieving a large sample of patients

• Collecting multiple variables, allowing for the making of a comprehensive statistical report

• Standardizing the methodology to be adopted, thus increasing accuracy

• Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities. ;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT02751086
• Study type: Observational
• Source: International Study Group on Minimally Invasive Surgery for Gastric Cancer
• Contact: Jacopo Desiderio, MD
• Phone: +393497531121
• Email: djdesi85@hotmail.it
• Status: Recruiting
• Start date: April 2016
• Completion date: December 2024